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The Changing Competencies of Pharmacovigilance Leadership

Significant transformations happened over the last decade regarding the role of pharmacovigilance (PV) departments in pharmaceutical organizations. This had a tremendous impact not only on the technical knowledge needed, but more importantly on the non-technical competencies that should be required for any PV role in pharma. This applies not only to positions with actual leadership responsibilities (i.e., with direct reports), but also to any PV role: each PV member has a significant part to play in fulfilling the pharmacovigilance mandate and in influencing the recognition of PV across the enterprise.

The traditional job description templates usually differentiate between technical competencies (i.e., what a person needs to know and be able to do – the knowledge and skills – to perform the job: the “what”) and behavioral competencies (i.e., the behaviors a person demonstrates in applying their knowledge and skills on the job: the “how”). Both types of competencies have significantly shifted over the last few years.

From a technical competency perspective, one major change has been to widen the application field of pharmacovigilance from one that is focused on case processing and compliance with reporting obligations, to one that is more comprehensive and cross-functional, inclusive of end-to-end risk/benefit assessment and risk management during the whole product life-cycle. This requires a significant involvement with the pre-marketing phase activities and the ability to develop collaborative processes for continuous assessment of the product benefit/risk ratio, both in qualitative and quantitative terms. The increasing complexity of regulations is also different, with a shortened cycle of regulatory and guidelines updates and global trend for dis-harmonization, compared to a relatively more stable historical cycle, driven by iterative loops of safety crisis leading to reinforcement of regulations every few years.

From a behavioral competency standpoint, the changes in the environment now require priority be given to non-traditional competencies, as compared to what was usually expected from a pool of health care professionals providing scientific expertise on drug safety topics. These new behavioral competencies are key success factors for a PV function, and at a broader level for the company as a whole. Here are some examples:

Change Management: following change is a common behavior, but the business environment now requires PV teams to be a driver for change and to be savvy in organizational transformations. The expectations regarding PV’s constant drive for operational excellence and highly strategic output pushes PV teams to continuously challenge the status quo, find operational efficiencies and understand the big picture, all without any sacrifice to compliance and quality. This means challenging individuals to always adapt, to abandon the prerogatives built over the years and to get out of their comfort zone to tackle a new set of challenges and responsibilities. The PV leader has a critical role in being a champion for transformation and creating new organizational design or ways of working. This also means creating a compelling case for change, engaging the team behind this new mission, managing the emotional impact on individuals and allowing all team members to learn and grow through this transformation.

Project Management: in a constantly changing environment where processes, systems and organizations evolve quickly, the execution of changes will depend a lot on fundamental project management skills. Being familiar with the concepts and actual implementation of major transformations will make a difference. Being at ease with key project management methodology and tools, the ability to establish a cross-functional project governance structure, establishing executive sponsorship or identifying and mitigating risks will allow an accelerated project implementation. Planning and executing a communication thread will be an essential strategy to minimize future obstacles and gain support during the journey to success.

Build Partnerships and Alliances: as more operational activities and sometimes core competencies are transferred to external vendors, it is essential to know how to build an efficient and smooth collaboration with these partners. Building relations of trust and confidence, establishing transparent and open communications, defining clear expectations on performance and accountability, and using empathy in problem resolution will all contribute to a successful partnership. The same approach will benefit partnerships on shared activities with internal functions such as regulatory, clinical research, marketing, medical affairs, quality and manufacturing.

Communication: the recognition of the work done by PV functions and support to any of its transformation projects will not come spontaneously from the rest of the company. This will happen only after significant outreach and educational efforts. The ability to draft and execute a multi-tier communication plan will help position PV as one of the key actors of the company. These communication efforts will also be a tremendous opportunity to learn what others do, recognize their strategic contributions and capture potential synergies. Solid communication skills will also obviously help discussions and decisions around scientific topics, such as product safety issues and risk management.

By increasing the relative importance of these behavioral competencies versus traditional and technical ones, by shifting the talent pool, and by grooming or reinforcing such competencies in the existing teams, pharmaceutical organizations will be more successful in adjusting to and anticipating the continuous pharmacovigilance paradigm shift, while fulfilling their mandate for excellence in patient safety.